Prescription medication · Ultra-Long-Acting Insulin
insulin degludec
Also sold as Tresiba.
Data updated 2026-05-15
- 22,011
- FDA reportsModerately reported
- 12
- InteractionsSeveral interactions
- 65% less
- Generic vs brandBig savings
- $32.52
- Brand price (NADAC)
What the data shows
insulin degludec (Tresiba) is a prescription Ultra-Long-Acting Insulin, reported at a middle-of-the-pack volume (22,011 FDA reports), whose generic runs roughly half the brand price or less (65% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$32.52/unit
Generic Price
$11.39/unit
Generic Savings
65%
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Common cold, Headache, Feeling sick to your stomach
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 22,011 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for insulin degludec, by number of reports
- Blood Glucose Increased
Blood Glucose Increased
3,617 reports
- Nausea 1,381
Nausea
1,381 reports
- Blood Glucose Decreased 1,252
Blood Glucose Decreased
1,252 reports
- Vomiting 894
Vomiting
894 reports
- Hypoglycaemia 886
Hypoglycaemia
886 reports
- Diarrhoea 876
Diarrhoea
876 reports
- Fatigue 861
Fatigue
861 reports
- Dyspnoea 760
Dyspnoea
760 reports
- Fall 673
Fall
673 reports
- Dizziness 652
Dizziness
652 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for insulin degludec each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where insulin degludec sits
insulin degludec has more FDA adverse-event reports than 57% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is insulin degludec; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 22,011 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.
Total Reports
22,011
Reports Mentioning Death
1,194
5.4% of reports — not proof of cause
Hospitalization Reports
6,329
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLOOD GLUCOSE INCREASED | 3,617 |
| 2 | NAUSEA | 1,381 |
| 3 | BLOOD GLUCOSE DECREASED | 1,252 |
| 6 | VOMITING | 894 |
| 7 | HYPOGLYCAEMIA | 886 |
| 8 | DIARRHOEA | 876 |
| 9 | FATIGUE | 861 |
| 10 | DYSPNOEA | 760 |
| 11 | FALL | 673 |
| 12 | DIZZINESS | 652 |
| 13 | HEADACHE | 634 |
| 14 | CONSTIPATION | 623 |
| 15 | MALAISE | 549 |
| 16 | GLYCOSYLATED HAEMOGLOBIN INCREASED | 545 |
| 17 | WEIGHT INCREASED | 542 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Fluoxetine can increase the effect of insulin, which makes your blood sugar more likely to drop to unsafe levels.
7.2 Effects of Delayed Gastric Emptying on Oral Medications Liraglutide-containing products, including XULTOPHY 100/3.6, cause a delay of gastric emptying, and thereby have the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree [see Clinical Pharmacology ( 12.3 )] . Nonetheless, caution should be exercised when oral medications are concomitantly administered with liraglutide containing products.
Mechanism: Liraglutide slows down the movement of food and medicine through your stomach, which can change how your body absorbs pills.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Both drugs work to lower blood sugar, so taking them at the same time can cause your blood sugar to drop too low.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: This medication can make your body more sensitive to insulin, which increases the risk of having low blood sugar.
Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Mechanism: Albuterol can decrease the blood-sugar-lowering effect of insulin. This can lead to higher blood sugar levels while you are using the medication.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of insulin degludec?
Does insulin degludec interact with other medications?
What drug class is insulin degludec?
Is there a generic version of insulin degludec?
Related Medications in Ultra-Long-Acting Insulin
Other drugs grouped near insulin degludec - same-class peers and common alternatives.
acarbose
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Acarbose is a medicine that helps lower blood sugar levels in people with type 2 diabetes.
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bromocriptine
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canagliflozin
Invokana
Invokana is a medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
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colesevelam
Welchol
Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for insulin degludec: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 22,011.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.42%.
- brexpiprazole Δ 0.01 pts · 15,755 reports · Atypical Antipsychotic 5.43%death share
- suvorexant Δ 0.02 pts · 12,687 reports · Orexin Receptor Antagonist 5.41%death share
- brivaracetam Δ 0.08 pts · 4,286 reports · Anticonvulsant (SV2A Ligand) 5.51%death share
- ustekinumab Δ 0.10 pts · 98,899 reports · Anti-IL-12/23 Monoclonal Antibody 5.53%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for insulin degludec
The FDA label for insulin degludec (sold under brand names such as Tresiba) classifies it as a prescription-only medication in the Ultra-Long-Acting Insulin class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 6 commonly reported side effects, including Common cold, Headache, Feeling sick to your stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 22,011 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $11.39 versus $32.52 for the brand - a 65% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 14, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages